A Safety and Effectiveness Study of Paliperidone Palmitate in Chinese Patients With Schizophrenia

NCT01947803 | Completed Phase 4

• 2 other identifiers: CR100855R092670SCH4018
• Study Type: interventional
• Target: 353
• Locations: 1 country
• Sites: 12

Brief Summary

The purpose of this study will be to evaluate the safety and treatment response of paliperidone palmitate administered to Chinese patients with schizophrenia.

Conditions

Schizophrenia

Keywords

Schizophrenia; Paliperidone; Safety; Effectiveness; Chinese

Outcome Measures

Primary Outcomes (1)

• The Number of Patients Who Experienced Adverse Events as a Measure of Safety and Tolerability

  Baseline, up to Week 29

Secondary Outcomes (2)

• Changes in Positive and Negative Syndrome Scale (PANSS) total scores from baseline at each visit between groups or subgroups (with psychiatry history <=5 years or >5 years)

  Baseline, Week 25

• Changes in Personal and Social Performance (PSP) Scale Scores from Baseline at Each Visit Between Groups or Subgroups (with Psychiatry History <=5 years or >5 years)

  Baseline, Week 25

Study Arms (1)

Paliperidone Palmitate

EXPERIMENTAL

Drug: Paliperidone Palmitate

Interventions

Paliperidone Palmitate DRUG

Paliperidone Palmitate is injected with a dose of 150 mg eq. on Day 1 and 100 mg eq. on Day 8 in the deltoid muscle, followed by a monthly flexible dose range of 75 - 150 mg eq. for injection, based on patients' tolerability and/or efficacy. Monthly doses can be administered in either the deltoid or gluteal muscle alternatively. All the antipsychotics should be discontinued prior to the first dose of study drug. Other antipsychotics are prohibited across this study.

Paliperidone Palmitate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent to participate in the study obtained -
• Confirmation of diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) within 5 years prior to screening
• Patient is willing and able to fill out self-administered questionnaires during the study
• confirmation that patient has been given an adequate dose of an appropriate oral antipsychotic for an adequate period of time before enrollment, but previous treatment is considered unsuccessful due to one or more of the following reasons: lack of efficacy, lack of tolerability or safety, lack of compliance and/or other reasons to switch to another antipsychotic medication

You may not qualify if:

• The patient's psychiatric diagnosis is due to the direct pharmacological effects of a drug of abuse substance or medication, or is due to a general medical condition (eg, clinically notable hypothyroidism)
• The patient is treatment resistant in the judgment of the investigator
• The patient meets the DSM-IV definition of substance dependence (except for nicotine and caffeine) within 6 months prior to entry
• The patient has a previously defined hypersensitivity (anaphylaxis-type reaction) to risperidone or paliperidone or excipients
• The patient has received treatment with a long-acting injectable antipsychotic within 3 injection cycles prior to baseline, received clozapine within 3 months prior to screening, received treatment with other investigational agents within 30 days of the screening visit, has participated in more than one investigational drug study in the past 12 months, or has planned use of other investigational drugs during the time frame of the study
• History or current symptoms of tardive dyskinesia, history of neuroleptic malignant syndrome, or evidence of clinically significant cardiovascular, renal, hepatic, gastrointestinal, neurological, endocrine, metabolic or pulmonary disease in the past 6 months

Sponsors & Collaborators

• Xian-Janssen Pharmaceutical Ltd.: lead

Study Sites (12)

Unknown Facility

Baoding, China

Location

Unknown Facility

Beijing, China

Location

Unknown Facility

Changsha, China

Location

Unknown Facility

Chengdu, China

Location

Unknown Facility

Guangzhou, China

Location

Unknown Facility

Hangzhou, China

Location

Unknown Facility

Kunming, China

Location

Unknown Facility

Nanjing, China

Location

Unknown Facility

Shijiazhuang, China

Location

Unknown Facility

Taiyuan, China

Location

Unknown Facility

Wuhan, China

Location

Unknown Facility

Xi'an, China

Location

Related Links

• Safety and Efficacy of Paliperidone Palmitate in 25-week Treatment on Chinese Patients with Schizophrenia: an Open-label, Single-arm, Multicenter Prospective Study

MeSH Terms

Conditions

Schizophrenia

Interventions

Paliperidone Palmitate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Xian-Janssen Pharmaceutical Ltd., China Clinical Trial

  Xian-Janssen Pharmaceutical Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2013
• First Posted: September 20, 2013
• Study Start: September 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 14, 2016

Record last verified: 2016-03

Locations

CN (12)